Clinical trial · Interventional
Mediastinoscopy-assisted Transhiatal Esophagectomy Versus Thoraco-laparoscopic Esophagectomy for Esophageal Cancer
Mediastinoscopy-assisted Transhiatal Esophagectomy (MATHE) Versus Thoraco-laparoscopic Esophagectomy (TLE) for Esophageal Cancer: a Multicenter Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Esophageal cancer is one of the major diseases that seriously threatens an individual's health and life. To reduce the incidence of postoperative complications and mortality of esophageal cancer, thoraco-laparoscopic oesophagectomy (TLE) has been recommended by many guidelines since the 2000s. Additionally, with developments in endoscopy technology in recent years, mediastinoscopy-assisted transhiatal esophagectomy (MATHE) has been used in clinical practice. In 2015, the first mediastinoscopy combined with laparoscopic radical esophagectomy was reported systematically by Hitoshi Fujiwara. This surgical procedure has been performed in many centres in China. However, there is no multicentre prospective randomized controlled study that explored the safety, feasibility and short-term clinical efficacy between mediastinoscopy-assisted transhiatal esophagectomy and thoraco-laparoscopic esophagectomy. We aim to evaluate the feasibility and safety of MATHE.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mediastinoscopy-assisted transhiatal esophagectomy | Procedure | — | UNRESOLVED |
| Thoraco-laparoscopic esophagectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Thoraco-laparoscopic esophagectomy
- description
- Treated by thoraco-laparoscopic esophagectomy in the centers with enough experience in esophageal resection and the volume ≧80 cases each year.
- interventionNames
- Procedure: Thoraco-laparoscopic esophagectomy
- type
- ACTIVE_COMPARATOR
- label
- Mediastinoscopy-assisted transhiatal esophagectomy
- description
- Treated by mediastinoscopy-assisted transhiatal esophagectomy in the centers with enough experience in esophageal resection and the volume ≧80 cases each year.
- interventionNames
- Procedure: Mediastinoscopy-assisted transhiatal esophagectomy
Primary outcomes (1)
- measure
- Postoperative respiratory complications
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years≤age≤ 80 years; * Histologically diagnosed with squamous cell carcinoma by endoscopic biopsy, cT1-3N0M0; * Primary tumour is located in the thoracic oesophagus * No clinical evidence of distant organ metastasis * No severe comorbidity, can tolerate anesthesia; * ECOG PS scores≤2; * The patients sign informed consents by themselves. Exclusion Criteria: * Cervical or abdominal oesophageal carcinoma; * Previous oesophagectomy, gastrectomy, or mediastinal surgery; * Current uncontrolled illness such as severe cardiac disease, uncontrollable hypertension or diabetes, or active bacterial infection; * Unable to tolerate tracheal intubation and general anaesthesia as determined by an anaesthesiologist preoperatively; * Pregnant or lactating women; * ECOG PS scores\>2; * Considered unsuitable, such as those who do not agree to participate in the trial.
References
Publications (0)
Data not yet available